COMPANY

Helsinn

HQ: Lugano, Switzerland source · helsinn.com ↗

FDA-cleared device company Clinical Phase 3

Keywords: oncology cancer Chemotherapy-induced Nausea and Vomiting Non Small Cell Lung Cancer Acute Myeloid Leukemia Myelodysplastic Syndrome Non-smokers Postoperative Nausea and Vomiting Nausea and Vomiting Chemotherapy-Induced Nausea Post Chemotherapy Drug and/or Toxin-induced Diarrhea CNS Tumor Recurrent WHO Grade II Glioma Myelodysplastic Syndromes Radiodermatitis Quality of Life Xerostomia Asialia Hyposalivation Mouth Dryness Breast Cancer Lung Cancer Colon Cancer Moderate to Heavy Smokers Nausea Vomiting Diarrhea Biliary Tract Cancer pracinostat Anamorelin Infigratinib

Location: Lugano, Switzerland · source · Oct 14, 2026

Profile checked Oct 10, 2026

32Trials (company is sponsor)

Timeline

Jul 7, 2025 Trial start Phase 2: Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC) source ↗
Jun 17, 2023 Trial start Phase 1: A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteers source ↗
Oct 1, 2021 Trial start Phase 1/Phase 2: Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations source ↗
Feb 1, 2021 Trial start Phase 4: Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) source ↗
May 6, 2019 Trial start Phase 3: A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (N source ↗
Mar 5, 2019 Trial start Phase 3: A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (N source ↗
Mar 16, 2018 Trial start Phase 3: A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Preven source ↗
Feb 8, 2018 Trial start Phase 1: A Study In Healthy Male Volunteers Designed To Investigate How A Radiolabelled Medicine Is Broken Down And Removed From The Body source ↗
Aug 31, 2017 Trial start Phase 2: PK/PD Study of Netupitant and Palonosetron in Pediatric Patients for Prevention of Chemotherapy-induced Nausea and Vomiting source ↗
Jul 31, 2017 Trial start Not phased (device or behavioral study): Effects of Aqualief® in Patients With Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer source ↗
Jun 23, 2017 Trial start Phase 3: An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia source ↗
Jun 15, 2017 Trial start Not phased (device or behavioral study): Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid® source ↗
Jun 1, 2017 Trial start Phase 2: A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes source ↗
2016-10 Trial start Not phased (device or behavioral study): Evaluation of the Effects of a Mixture of Amino Acids (Amixea) on Lean Body Mass and Muscle Strengh of Patients With Unresectable Advanced Non-small Cell Lung Cancer source ↗
2015-11 Trial start Phase 3: A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiting source ↗
2015-10 Trial start Not phased (device or behavioral study): Effects of Somnage® in the Management on Sleep and Mood in Cancer Patients source ↗
2015-10 Trial start Phase 3: An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting source ↗
2015-01 Trial start Phase 2: Dose Finding Study in Colorectal Cancer Patients Receiving 5-FU-based Chemotherapy to Assess the Efficacy of Elsiglutide in the Prevention of Chemotherapy Induced Diarrhea (CID) source ↗
2014-05 Trial start Phase 1: Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects source ↗
2014-02 Trial start Early phase 1: Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult Subjects source ↗
Dec 24, 2013 Trial start Phase 2: Safety and Efficacy Study of Pracinostat With Azacitadine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) source ↗
2013-12 Trial start 2: Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA source ↗
2013-06 Trial start 2: Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome source ↗
2013-06 Trial start Not phased (device or behavioral study): Efficacy Study of Ginger (Zingiber Officinale) Extract "Ginpax" to Manage Nausea in Cancer Patients Receiving High Emetogenic Treatments and Standard Anti-emetogenic Therapy source ↗
2012-02 Trial start Phase 2: Proof-of-Concept Study in Cancer Patients to Assess Efficacy of Elsiglutide in Preventing Chemotherapy-Induced Diarrhea source ↗

Showing 25 of 32 dated events.

Upcoming milestones

2027-10 (ESTIMATED) · Phase 2 · Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC) · NCT06904235

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 32

Record	Title	Phase	Status	Start	Primary completion
NCT03743051	A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) - 1	Phase 3	Completed	Mar 5, 2019	Feb 11, 2023 (actual)
NCT03743064	A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) - 2	Phase 3	Completed	May 6, 2019	Dec 27, 2022 (actual)
NCT06904235	Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC)	Phase 2	Recruiting	Jul 7, 2025	2027-10 (estimated)
NCT04817189	Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk)	Phase 4	Completed	Feb 1, 2021	Jul 2, 2024 (actual)
NCT06840769	A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteers	Phase 1	Terminated	Jun 17, 2023	Oct 18, 2023 (actual)
NCT03204279	PK/PD Study of Netupitant and Palonosetron in Pediatric Patients for Prevention of Chemotherapy-induced Nausea and Vomiting	Phase 2	Completed	Aug 31, 2017	Sep 30, 2019 (actual)
NCT02383810	Dose Finding Study in Colorectal Cancer Patients Receiving 5-FU-based Chemotherapy to Assess the Efficacy of Elsiglutide in the Prevention of Chemotherapy Induced Diarrhea (CID)	Phase 2	Completed	2015-01	2016-02 (actual)
NCT05222165	Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations	Phase 1/Phase 2	Withdrawn	Oct 1, 2021	Dec 16, 2022 (actual)
NCT03151408	An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia	Phase 3	Terminated	Jun 23, 2017	Aug 20, 2020 (actual)
NCT03151304	A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes	Phase 2	Terminated	Jun 1, 2017	Dec 1, 2020 (actual)
NCT01363479	An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting	Phase 3	Completed	2011-07	2012-11 (actual)
NCT01912274	Safety and Efficacy Study of Pracinostat With Azacitadine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)	Phase 2	Completed	Dec 24, 2013	Nov 8, 2016 (actual)
NCT03255980	Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid®	Not phased (device or behavioral study)	Completed	Jun 15, 2017	Feb 20, 2019 (actual)
NCT03403712	A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer	Phase 3	Completed	Mar 16, 2018	Sep 19, 2018 (actual)
NCT03601962	Effects of Aqualief® in Patients With Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer	Not phased (device or behavioral study)	Terminated	Jul 31, 2017	Jan 22, 2020 (actual)
NCT03495934	A Study In Healthy Male Volunteers Designed To Investigate How A Radiolabelled Medicine Is Broken Down And Removed From The Body	Phase 1	Completed	Feb 8, 2018	Feb 28, 2018 (actual)
NCT02883790	Effects of Somnage® in the Management on Sleep and Mood in Cancer Patients	Not phased (device or behavioral study)	Terminated	2015-10	2018-02 (actual)
NCT01873703	Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome	2	Completed	2013-06	2015-11 (actual)
NCT02557035	An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting	Phase 3	Completed	2015-10	2016-03 (actual)
NCT02517021	A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiting	Phase 3	Completed	2015-11	2016-08 (actual)
NCT01993641	Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA	2	Completed	2013-12	2015-05 (actual)
NCT02058784	Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult Subjects	Early phase 1	Completed	2014-02	2014-03 (actual)
NCT02118909	Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects	Phase 1	Completed	2014-05	2014-06 (actual)
NCT02877966	Evaluation of the Effects of a Mixture of Amino Acids (Amixea) on Lean Body Mass and Muscle Strengh of Patients With Unresectable Advanced Non-small Cell Lung Cancer	Not phased (device or behavioral study)	Withdrawn	2016-10	2018-08 (estimated)
NCT01887314	Efficacy Study of Ginger (Zingiber Officinale) Extract "Ginpax" to Manage Nausea in Cancer Patients Receiving High Emetogenic Treatments and Standard Anti-emetogenic Therapy	Not phased (device or behavioral study)	Completed	2013-06	2015-09 (actual)
NCT00828295	Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients	Phase 3	Completed	2008-08	2008-12 (actual)
NCT01339260	An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting	Phase 3	Completed	2011-04	2012-11 (actual)
NCT01376297	A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting	Phase 3	Completed	2011-07	2012-09 (actual)
NCT01442376	Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients	Phase 3	Completed	2011-09	2012-10 (actual)
NCT01395901	Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients	Phase 3	Completed	2011-06	2012-03 (actual)
NCT01543451	Proof-of-Concept Study in Cancer Patients to Assess Efficacy of Elsiglutide in Preventing Chemotherapy-Induced Diarrhea	Phase 2	Completed	2012-02	2013-01 (actual)
NCT00090025	XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors	Phase 3	Terminated	2004-09	2006-11 (actual)